Comparison of 3 Different Density Levobupivacaine Solutions + Fentanyl for Spinal Anaesthesia for Caesarean Delivery.

Balikesir University

Status and phase: Completed; Phase 4

Conditions: Anesthesia

Treatments: Drug: Chirocaine Heavy 80; Drug: Chirocaine Heavy 40; Drug: Chirocaine Heavy 60; Drug: Chirocaine %0.5

Study type: Interventional

Funder types: Other

Identifiers

NCT03956303

osagir2

Details and patient eligibility

About

The investigator's aim is to compare the efficacy of 3 levobupivacaine solutions with different density on spinal anesthesia for caesarean delivery.

Full description

Patients scheduled for elective caesarean delivery were separated into 4 groups. Spinal anesthesia was performed with one of the following regimens.

Group 1: Levobupivacaine 8 mg + 20 mcg Fentanyl Group 2: Levobupivacaine 8 mg + 20 mcg Fentanyl + 40 mg Dextrose Group 3: Levobupivacaine 8 mg + 20 mcg Fentanyl + 60 mg Dextrose Group 4: Levobupivacaine 8 mg + 20 mcg Fentanyl + 80 mg Dextrose After anesthesia induction motor block was evaluated via bromage scale and sensory block via pinprick test every 3 minutes for the first 15 minutes, and every 5 minutes up to 60 minutes. Maximum sensory block level, time to reach maximum block level, time needed to achieve T10 sensory level were recorded.

Baby delivery time, and operation duration were also recorded. Time to two segment regression of maximum sensory block, motor block recovery time and time to S2 regression of sensory block will be recorded.

Hemodynamic data, nausea vomiting, were also recorded throughout surgery at the same evaluation periods and postoperative period.

The surgeon will also evaluate the abdominal relaxation surgical block quality as good, medium and poor.

The patient will evaluate spinal block analgesia quality as good, medium or poor.

Pain scores are going to be evaluated by VAS at the beginning, uterine incision and during abdominal closure. Time for first analgesic requirement and postoperative pain is also going to be evaluated by VAS.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA I-II
• Pregnancy at Term
• Scheduled for elective caesarean delivery

Exclusion criteria

• contraindication for spinal anesthesia
• drug allergy
• pregnancy related disorders (hypertension, placenta previa, fetal problems)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 4 patient groups

Plain Levobupivacaine (Chirocaine (% 0.5)

Active Comparator group

Description:

Levobupivacaine 8 mg (Chirocaine (% 0.5)) + 20 mcg fentanyl Chirocaine Plain

Treatment:

Drug: Chirocaine %0.5

Levobupivacaine (Chirocaine % 0,75) + dextrose 40

Active Comparator group

Description:

Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 40 Chirocaine Heavy 40

Treatment:

Drug: Chirocaine Heavy 40

Levobupivacaine (Chirocaine % 0,75) + dextrose 60

Active Comparator group

Description:

Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 60 Chirocaine Heavy 60

Treatment:

Drug: Chirocaine Heavy 60

Levobupivacaine (Chirocaine % 0,75) + dextrose 80

Active Comparator group

Description:

Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 80 Chirocaine Heavy 80

Treatment:

Drug: Chirocaine Heavy 80